| Device Classification Name |
system, x-ray, tomography, computed
|
|---|
| 510(K) Number |
K113548 |
|---|
| Models |
1000-0 (115 VAC),
1001-0 (230 VAC),
1002-0 (100 VAC),
1003-0 (200 VAC)
|
| Device Name |
PEDCAT |
|---|
| Applicant |
| CURVEBEAM, LLC |
| 175 titus ave |
| suite 300 |
|
warrington,
PA
18976
|
|
| Contact |
david w cowan |
| Regulation Number | 892.1750
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 12/01/2011 |
|---|
| Decision Date | 04/10/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Radiology
|
|---|
| Review Advisory Committee |
Radiology
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
